Asacol    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
97Ulcerative colitis64

97. Ulcerative colitis    [ 2,269 clinical trials,   1,331 drugs,   (DrugBank: 241 drugs),   114 drug target genes,   181 drug target pathways]
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
64 / 2,269 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002070-31-DK
(EUCTR)
05/09/201924/06/2019Compliance to treatment with new single-pill 5-ASA for patients with Ulcerative Colitis (EASI-trial)Adherence of a 1.600 mg single tablet 5-ASA treatment of Ulcerative colitis (EASI-trial) Ulcerative colitis (UC) belongs to the group of inflammatory bowel diseases. The disease course is unpredictable and characterised by chronic inflammation of the colonic mucosa, where acute attacks are followed by periods of remission. Development of UC is characterized by a dysregulated immune response and barrier dysfunction caused by genetic susceptibility and environmental triggers. UC only involves the colon, starting in the rectum and extending to proximal segments of the colon.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Asacol®
INN or Proposed INN: MESALAZINE
Copenhagen University Hospital HvidovreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 4Denmark
2EUCTR2013-000366-11-RO
(EUCTR)
25/03/201511/03/2015Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Serbia;Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
3EUCTR2013-000366-11-SK
(EUCTR)
19/06/201421/05/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Latvia;Sweden
4EUCTR2013-000366-11-BG
(EUCTR)
23/04/201406/03/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
5EUCTR2013-000366-11-LV
(EUCTR)
14/03/201407/02/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2013-000366-11-LT
(EUCTR)
10/03/201422/01/2014Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
7EUCTR2013-000366-11-HU
(EUCTR)
24/02/201428/11/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
8JPRN-JapicCTI-142475
24/12/2013Phase 3 Clinical Trial with MD-0901Phase 3 Clinical Trial with MD-0901 Mild to moderate active ulcerative colitisIntervention name : MD-0901
INN of the intervention : Mesalazine
Dosage And administration of the intervention : Mesalazine 4.8 g/d are administrated orally once daily after breakfast for 8 weeks.
Control intervention name : Asacol tablet
INN of the control intervention : Mesalazine
Dosage And administration of the control intervention : Mesalazine 3.6 g/d are administrated orally 3 times daily after each meal for 8 weeks.
MOCHIDA PHARMACEUTICAL CO., LTD.NULL16BOTH250Phase 3NULL
9EUCTR2013-000366-11-PL
(EUCTR)
12/12/201305/09/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Latvia;Sweden
10EUCTR2013-000366-11-ES
(EUCTR)
07/10/201312/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Latvia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2013-000366-11-CZ
(EUCTR)
12/09/201305/06/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
12EUCTR2013-000366-11-BE
(EUCTR)
02/09/201311/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
13EUCTR2013-000366-11-FI
(EUCTR)
20/08/201305/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
14EUCTR2013-000366-11-IE
(EUCTR)
17/07/201316/05/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
15EUCTR2013-000366-11-DK
(EUCTR)
10/07/201310/07/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01903252
(ClinicalTrials.gov)
July 20139/7/2013TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/Day for the Treatment of Active Ulcerative ColitisAcute Ulcerative ColitisDrug: TP05;Drug: Asacol 400 mgTillotts Pharma AGNULLCompleted18 YearsN/AAll817Phase 3Switzerland;Netherlands
17EUCTR2013-000366-11-SE
(EUCTR)
28/06/201313/05/2013Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TP05
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
INN or Proposed INN: MESALAZINE
Tillotts Pharma AGNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
18JPRN-UMIN000010906
2013/06/1010/06/2013The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission. Ulcerative ColitisA 24-week administration of 4.8g/day of Asacol
A 24-week administration of the mesalazine which the patients have taken before the treatment of 4.8g/day of Asacol as induction therapy
Chiba University HospitalNULLComplete: follow-up complete15years-old70years-oldMale and Female60Phase 2Japan
19NCT04032652
(ClinicalTrials.gov)
December 20124/12/2012Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving AsacolMeasurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on AsacolUlcerative ColitisProcedure: Rectal dialysis;Drug: Rectal dialysisNorthShore University HealthSystemNULLTerminated18 Years45 YearsAll2Phase 2NULL
20NCT01257399
(ClinicalTrials.gov)
November 20108/12/2010Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission PhaseComparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission PhaseUlcerative Colitis in RemissionDrug: Asacol®;Drug: MesalazineTillotts Pharma AGZeria PharmaceuticalCompleted18 Years64 YearsBoth251Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01257386
(ClinicalTrials.gov)
November 20108/12/2010Comparative Efficacy and Safety Study in Patients With Active Ulcerative ColitisComparative Efficacy and Safety Study in Patients With Active Ulcerative ColitisActive Ulcerative ColitisDrug: Asacol®;Drug: MesalazineTillotts Pharma AGZeria PharmaceuticalCompleted18 Years64 YearsBoth251Phase 3China
22NCT01059344
(ClinicalTrials.gov)
November 200928/1/2010Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative ColitisA Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative ColitisUlcerative ColitisDrug: MesalaminTillotts Pharma AGNULLCompleted18 YearsN/AAll281Phase 3Belarus;India;Turkey;Ukraine
23EUCTR2009-011608-51-DE
(EUCTR)
09/10/200921/07/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Germany;Sweden
24NCT01004185
(ClinicalTrials.gov)
October 200927/10/2009Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative ColitisA Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative ColitisUlcerative ColitisDrug: Asacol 400 mgWarner ChilcottNULLTerminated5 Years17 YearsAll39Phase 3United States;Canada;Croatia;Poland;Romania;Russian Federation
25EUCTR2004-004184-29-DK
(EUCTR)
10/09/200910/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
830Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2009-011608-51-SE
(EUCTR)
17/08/200922/06/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
60Germany;Sweden
27EUCTR2009-011608-51-BE
(EUCTR)
03/08/200923/06/2009A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative ColitisA Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Belgium;Germany;Sweden
28EUCTR2008-007292-25-IT
(EUCTR)
24/03/200916/03/2009AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08 Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure)
MedDRA version: 9.1;Level: LLT;Classification code 10024123;Term: Left-sided ulcerative (chronic) colitis
Trade Name: MEZAVANT
INN or Proposed INN: Mesalazine
Trade Name: ASACOL
INN or Proposed INN: Mesalazine
GIULIANINULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
29NCT00713310
(ClinicalTrials.gov)
December 20089/7/2008Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative ColitisStudy to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative ColitisUlcerative ColitisDrug: Asacol 400 mgWarner ChilcottNULLCompleted5 Years17 YearsAll83Phase 3United States;Canada;Croatia;Poland;Romania
30NCT00679432
(ClinicalTrials.gov)
June 200814/5/2008(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative ColitisEfficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.Ulcerative ColitisProcedure: Blood sampling, endoscopy;Drug: budesonide-MMX® 6 mg;Drug: budesonide-MMX® 9 mg;Drug: Placebo;Drug: Asacol® 400 mgBausch Health Americas, Inc.NULLCompleted18 Years75 YearsAll510Phase 3United States;Canada;India;Mexico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2007-004732-23-PL
(EUCTR)
05/05/200812/05/2008A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.)A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.) Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
Product Name: Mesalamine
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE
EMET Pharmaceuticals, LLCNULLNot RecruitingFemale: yes
Male: yes
435Estonia;Latvia;Poland
32EUCTR2007-004732-23-LV
(EUCTR)
27/02/200828/02/2008A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative ColitisA Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Mesalamine Delayed Release Tablets 400mg
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE
EMET Pharmaceuticals LLCNULLNot RecruitingFemale: yes
Male: yes
435Estonia;Latvia;Poland
33EUCTR2004-004184-29-NL
(EUCTR)
15/01/200817/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
826Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
34NCT01045018
(ClinicalTrials.gov)
January 200817/12/2009A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative ColitisBE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Reference Listed Drug ASACOL® Delayed Release Tablets 400 mg in Patients With Mild to Moderately Active Ulcerative ColitisMild to Moderate Ulcerative ColitisDrug: Placebo;Drug: MesalamineEMET Pharmaceuticals, LLCEagle Pharmaceuticals, Inc.Completed18 YearsN/ABothPhase 3NULL
35EUCTR2004-004184-29-PT
(EUCTR)
14/12/200711/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Hungary;Portugal;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2004-004184-29-SE
(EUCTR)
22/11/200727/09/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
830Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
37EUCTR2007-004732-23-EE
(EUCTR)
22/10/200723/10/2007A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative ColitisA Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Mesalamine Delayed Release Tablets 400mg
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE
EMET Pharmaceuticals LLCNULLNot RecruitingFemale: yes
Male: yes
435Estonia;Latvia;Poland
38NCT00505778
(ClinicalTrials.gov)
July 200720/7/2007A Comparison of Once a Day Dose Compared to 2 Doses/DayA Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative ColitisUlcerative ColitisDrug: Mesalamine Once-Daily;Drug: Mesalamine Twice-DailyWarner ChilcottNULLCompleted18 YearsN/AAll1027Phase 3United States;Canada;Puerto Rico
39NCT00708656
(ClinicalTrials.gov)
October 20068/4/2008The Colitis Once Daily Asacol StudyA Randomized, Single-Blind Study to Assess Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily Versus Divided Doses 3 Times Daily for 12 Months in Maintenance of Remission of Ulcerative Colitis.Ulcerative ColitisDrug: mesalazine (Asacol®)Cardiff and Vale University Health BoardProcter and GambleCompleted18 YearsN/AAll213Phase 3United Kingdom
40NCT00343850
(ClinicalTrials.gov)
September 200621/6/2006Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative ColitisOnce Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis: A Randomized Pilot TrialUlcerative ColitisDrug: Asacol (mesalamine)University of ChicagoProcter and GambleCompleted18 YearsN/ABoth30Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2006-001310-32-LT
(EUCTR)
17/07/200615/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
42NCT00349388
(ClinicalTrials.gov)
July 20065/7/2006Safety and Compliance of Taking Mesalamine Once a Day in Pediatric PatientsA Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative ColitisUlcerative ColitisDrug: AsacolAnnette LangsederProcter and GambleTerminated6 Years18 YearsAll1N/AUnited States
43EUCTR2006-001310-32-HU
(EUCTR)
29/06/200623/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
44EUCTR2006-001310-32-CZ
(EUCTR)
26/06/200617/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
45EUCTR2006-001310-32-EE
(EUCTR)
16/06/200627/04/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT00350415
(ClinicalTrials.gov)
June 20066/7/2006A Double Blind Study for the Treatment of Acute Ulcerative ColitisA Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.Ulcerative ColitisDrug: MesalamineWarner ChilcottNULLCompleted18 Years75 YearsBoth772Phase 3United States;Belarus;Canada;Croatia;Czech Republic;Estonia;Hungary;Latvia;Lithuania;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro
47NCT00408174
(ClinicalTrials.gov)
May 20064/12/2006Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative ColitisA Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative ColitisInflammatory Bowel Disease;Ulcerative ColitisDrug: Balsalazide disodiumBausch Health Americas, Inc.NULLCompleted18 YearsN/AAll400Phase 3United States
48EUCTR2006-001310-32-LV
(EUCTR)
28/04/200622/08/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III Ulcerative ColitisProduct Name: Asacol 800mg tablet
INN or Proposed INN: mesalazine
Product Name: Asacol 400mg tablet
INN or Proposed INN: mesalazine
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
470Hungary;Czech Republic;Estonia;Latvia;Lithuania
49EUCTR2005-002784-91-GB
(EUCTR)
06/02/200624/11/2005A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol)A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol) Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.Cardiff and Vale NHS TrustNULLNot Recruiting Female: yes
Male: yes
630Phase 3United Kingdom
50NCT00254618
(ClinicalTrials.gov)
October 200514/11/2005A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.Study to Determine the Pharmacokinetics of Mesalamine Following Administration of 30, 60, and 90 mg/kg/Day as 400 mg Delayed-release Tablets Given Every 12 Hours for 28 Days to Children/Adolescents With Active Ulcerative Colitis.Ulcerative ColitisDrug: mesalamineWarner ChilcottNULLTerminated5 Years17 YearsBoth34Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2004-004184-29-DE
(EUCTR)
06/06/200501/03/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitisProduct Name: None given
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
410Phase 3Portugal;Hungary;Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Spain;Sweden
52EUCTR2004-004184-29-GB
(EUCTR)
31/05/200523/02/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Shire Pharmaceutical Development LtdNULLNot Recruiting Female: yes
Male: yes
826Phase 3Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
53EUCTR2004-004184-29-ES
(EUCTR)
05/05/200503/04/2006A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis.A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. Ulcerative colitis
MedDRA version: 3.2;Level: LLT;Classification code 10045365
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
410Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
54EUCTR2004-004184-29-CZ
(EUCTR)
13/04/200511/04/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.
Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Portugal;Hungary;Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Spain;Sweden
55NCT00151892
(ClinicalTrials.gov)
April 20057/9/2005Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative ColitisA Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative ColitisUlcerative ColitisDrug: SPD476;Drug: AsacolShireNULLCompleted18 YearsN/AAll829Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;Czech Republic;Denmark;France;Germany;Hungary;India;Korea, Republic of;Mexico;Netherlands;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2004-004184-29-HU
(EUCTR)
30/03/200510/02/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.
Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
826Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
57EUCTR2004-000611-25-IE
(EUCTR)
19/10/200416/08/2004A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - COREA Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE Maintenance of remission of ulcerative colitisProduct Name: OPC-6535
Product Code: OPC-6535
Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid
Trade Name: Asacol (mesalamine) Delayed-release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalamine
Other descriptive name: 5-amino-2-hydroxybenzoic acid
Otsuka Maryland Research Institute, Inc.NULLNot RecruitingFemale: yes
Male: yes
1725Phase 3Hungary;Ireland
58EUCTR2004-000611-25-HU
(EUCTR)
15/10/200421/07/2004A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - COREA Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE Maintenance of remission of ulcerative colitisProduct Name: OPC-6535
Product Code: OPC-6535
Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid
Trade Name: Asacol (mesalamine) Delayed-release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalamine
Other descriptive name: 5-amino-2-hydroxybenzoic acid
Otsuka Maryland Research Institute, Inc.NULLNot RecruitingFemale: yes
Male: yes
1725Phase 3Hungary;Ireland
59NCT00092508
(ClinicalTrials.gov)
May 200422/9/2004CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) RemissionPhase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis RemissionUlcerative ColitisDrug: OPC-6535;Drug: Asacol®Otsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years80 YearsBoth1725Phase 3United States
60NCT00548574
(ClinicalTrials.gov)
December 200323/10/2007Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative ColitisA Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine;Drug: MesalazineShireNULLCompleted18 YearsN/ABoth343Phase 3Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT00194818
(ClinicalTrials.gov)
June 200315/9/2005Asacol Dosing Study for Active Ulcerative ColitisOpen Label Safety and Efficacy Trial of Twice Daily Dosing of Asacol vs. Three Times Per Day Dosing for the Induction of Remission in Active Ulcerative ColitisUlcerative ColitisDrug: Asacol (mesalamine)University of WashingtonProcter and GambleCompleted18 Years80 YearsBoth7Phase 4United States
62NCT00577473
(ClinicalTrials.gov)
February 200119/12/2007Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/DayUlcerative ColitisDrug: mesalamineWarner ChilcottNULLCompleted18 Years65 YearsAll301Phase 3United States
63NCT00073021
(ClinicalTrials.gov)
September 200013/11/2003Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative ColitisA Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative ColitisUlcerative ColitisDrug: Asacol 800 mg (mesalamine);Drug: Asacol 400 mg (mesalamine)Warner ChilcottNULLCompleted18 Years75 YearsAll386Phase 3United States;Canada;Puerto Rico
64EUCTR2007-005702-49-PL
(EUCTR)
17/06/2009A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP IIA Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II Mildly-to-Moderately Active Ulcerative Colitis in Children and Adolescents
MedDRA version: 11.0;Level: LLT;Classification code 10045365;Term:
Trade Name: Asacol
Product Name: Asacol
Product Code: NA
INN or Proposed INN: MESALAZINE
Procter & Gamble PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Poland